An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.

University of Cincinnati

Status: Completed

Conditions: Stimulant Dependence

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00628927

5U10DA013732 (U.S. NIH Grant/Contract)

U10DA013732 (U.S. NIH Grant/Contract)

NIDA-CTN-0031A

Details and patient eligibility

About

The purpose of this study is to determine whether performance on neurocognitive measures predicts treatment outcomes in individuals with substance abuse disorders. A second purpose is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in people with substance abuse disorders to that of people who do not have substance abuse disorders.

Full description

The primary objective of this study is to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with Methamphetamine use disorders. Secondary objectives include evaluating whether:

1. performance on various neurocognitive measures, including the Stroop, Rey Auditory-Verbal Learning Test (RAVLT), Iowa Gambling Task (GT), Wisconsin Card Sorting Task (WCST), the Barratt Impulsiveness Scale version -11 (BIS-11), and the Frontal Systems Behavior Scale (FrSBe) is predictive of treatment attrition and stimulant use outcomes in METH/cocaine abusers;
2. neurocognitive test performance is associated with oxidative damage, a severe consequence of oxidative stress, in METH/cocaine abusers;
3. oxidative damage is predictive of treatment attrition and substance use outcomes in METH/cocaine abusers,
4. oxidative damage in METH/cocaine abusers is significantly greater than that of a normal comparison group and
5. exploratory analyses reveal a significant relationship among oxidative stress, neurocognitive function, and treatment outcomes in METH/cocaine abusers.

Enrollment: 217 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (METH and/or Cocaine Dependent Group):

• be randomized into the CTN-0031 (STAGE-12) trial
• current abuse or dependence for METH and/or cocaine
• endorse METH and/or cocaine as the primary drug of choice
• able to correctly distinguish the colored stimuli on the Stoop task.

Exclusion Criteria (METH and/or Cocaine Dependent Group):

• history of stroke
• history of a seizure disorder

Inclusion Criteria (Non-METH and/or Cocaine Dependent Group):

• be 18 years of age or older
• be able to understand the study and provide written informed consent in English

Exclusion Criteria (Non-METH and/or Cocaine Dependent Group):

• history of stroke
• history of a seizure disorder
• positive urine toxicology screen
• screen positive for Major Depressive Syndrome, other Depressive Syndrome, Panic Syndrome, or other Anxiety Syndrome
• meet criteria for ADHD
• have HIV/AIDS
• history of an injury in which consciousness was lost for more than 30 minutes
• meet DSM-IV criteria for dependence (either current or lifetime) for any psychoactive substance other than nicotine or for abuse (both current and lifetime) for any psychoactive substance other than nicotine or for alcohol for which a life-time history of abuse is allowed

Trial design

217 participants in 2 patient groups

METH and/or cocaine dependent group

Description:

The METH and/or cocaine dependent group were also enrolled in CTN0031 (NCT00573183) and seeking treatment. This group will be analyzed based on whether or not they completed treatment as defined by the study.

Non METH and/or cocaine dependent group

Description:

The Non METH and/or cocaine dependent group participants are normal controls recruited from the community.